Bill Marler, food safety advocate and foodborne illness attorney since 1993, whose Seattle area law firm, Marler Clark’s work was recently profiled in the Netflix documentary “Poisoned,” The Dirty Truth about your Food, is calling on ByHeart to pay the medical bills and lost wages of the families of victims of the Botulism outbreak in the United States that has so far sickened 13.
The FDA and CDC, in collaboration with the Infant Botulism Treatment and Prevention Program (IBTPP), and state and local partners, are investigating a multistate outbreak of 13 infant botulism illnesses from 10 states: Arizona, California, Illinois, Minnesota, New Jersey, Oregon, Pennsylvania, Rhode Island, Texas and Washington. Laboratory confirmation for some cases is ongoing. There are no deaths reported at this time. The IBTPP reported an increase in number of botulism type A infections among infants consuming ByHeart powdered infant formula from August 2025 to November 2025. All 13 cases included in this outbreak are reported to have consumed ByHeart brand powdered infant formula.
According to the California Department of Health, “Infant botulism is a very rare disease that occurs when babies inhale or swallow spores of the toxin-producing bacteria that cause infant botulism, which leads to progressive muscle weakness including trouble breathing if not treated in time.” said Dr. Erica Pan, CDPH Director and State Public Health Officer. “We have tested a sample of the specific powdered infant formula linked with these cases and preliminary tests are positive. We are urging parents to stop using ByHeart formula immediately.”
ByHeart has chosen to downplay its role. According to a ByHeart release, ByHeart was notified by the FDA on November 7, 2025 of an estimated 83 cases of infant botulism that were reported nationwide since August 2025. Of these, the FDA also noted that 13 infants received ByHeart formula at some point. The FDA has not identified a direct link between any infant formula and these cases and there is no historical precedent of infant formula causing infant botulism. Botulism is extremely uncommon in dairy products or infant formula, and is naturally occurring in environmental sources like soil, select vegetables, and dust.
According to the ByHeart’s website, ByHeart Whole Nutrition Infant Formula was sold through their website ByHeart.com and through retail stores nationwide, including Amazon, Kroger, Walmart, Whole Foods, Target, SamsClub.com and others. ByHeart’s Corporate Headquarters is at 131 Varick Street, New York, NY. Manufacturing facilities are in Reading, PA, Allerton, IA, and Portland, OR.
“Unfortunately, those infants sickened will likely rise in the coming weeks,” Marler said. “The cost of treating victims of Botulism infections can run in the tens of thousands of dollars, or in a severe case, even in the hundreds of thousands of dollars. These families need ByHeart to do more than promise to cooperate in the investigation into this outbreak. They need to know that ByHeart intends to fulfill their corporate responsibility by looking out for their customers,” added Marler.
Marler noted that over the last two decades in other outbreak-situations, companies such as Chi-Chi’s, Dole, Jack in the Box, Conagra, Odwalla and Sheetz advanced medical costs for outbreak victims whose illnesses were traced to their food products.
William “Bill” Marler has been a food safety lawyer and advocate since the 1993 Jack-in-the-Box E. coli Outbreak which was chronicled in the book, “Poisoned” and in the recent Emmy Award winning Netflix documentary by the same name. Bill work has been profiled in the New Yorker, “A Bug in the System;” the Seattle Times, “30 years after the deadly E. coli outbreak, A Seattle attorney still fights for food safety;” the Washington Post, “He helped make burgers safer, Now he is fighting food poisoning again;” and several others.
Dozens of times a year Bill speaks to industry and government throughout the United States, Canada, Europe, Africa, China and Australia on why it is important to prevent foodborne illnesses. He is also a frequent commentator on food litigation and food safety on Marler Blog. Bill is also the publisher of Food Safety News.